GOST R 59921.2-2021 - Artificial intelligence systems in clinical medicine. Part 2. Program and methodology of technical validation

Scope: This standard establishes general approaches to conducting technical testing of artificial intelligence systems. Technical tests are carried out in accordance with the program and methodology to assess the compliance of the characteristics of the artificial intelligence system with the requirements of the manufacturer’s technical and operational documentation, declared standards, applicable regulatory requirements, etc., including for the purpose of deciding on the possibility of conducting subsequent clinical trials [1 ]. This standard applies to artificial intelligence systems as software that is a medical device. This standard defines the methodological basis for drawing up a program and methodology for technical testing of artificial intelligence systems

GOST R 59921.2-2021 history

2021 GOST R 59921.2-2021 Artificial intelligence systems in clinical medicine. Part 2. Program and methodology of technical validation